MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II XR INS XLPE MED 3-4 RT 10MM; PROST, KNEE, PATELLOFEM, SEMI-CONS, CEMENTED, POLY/METAL/POLY

Model Number	74023732
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, the insert could not be inserted well.The back-up (same size, different lot) was opened and tried to insert.But the back-up could not be inserted well either.The other back-up (different size) was utilized, finally it was inserted and locked well.This incident caused 15 minutes delay of surgery.No patient harm was reported.
Additional Manufacturer Narrative
H3, h6: it was reported that during surgery, the insert could not be inserted well.So that the back-up (same size, different lot) was opened and tried to insert.But the back-up could not be inserted well, neither.The other back-up (different size) was utilized, finally it was inserted and locked well.This incident caused 15 minutes delay of surgery.The affected complaint device, used in treatment, was returned and evaluated.A visual inspection of the returned device shows damage around the edges of the device.Scratches are observed on the surface of the part, probably from the attempted insertion.A dimensional evaluation was not performed as the damage/deformation at several features of the device would not allow for accurate measurement.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.A clinical evaluation noted that no patient harm was reported.Therefore, no further assessment is warranted at this time.Some potential causes could include but are not limited to size of device or surgical technique used.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: JRNY II XR INS XLPE MED 3-4 RT 10MM
• Common Device Name: PROST, KNEE, PATELLOFEM, SEMI-CONS, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10557307
• Report Number: 1020279-2020-04689
• Device Sequence Number: 3749733
• Product Code: JWH
• UDI-Device Identifier: 00885556613085
• UDI-Public: 00885556613085
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/09/2026
• Device Model Number: 74023732
• Device Catalogue Number: 74023732
• Device Lot Number: 16GM06768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 05/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention